AstraZeneca’s Klygefa receives a positive EU recommendation

European medicines advisers recommended AstraZeneca ($AZN)’s Klygefa, or gefurulimab, as an add-on to standard treatment for adults with generalized myasthenia gravis who are positive for anti-acetylcholine receptor antibodies. The Alexion medicine is designed for once-weekly subcutaneous self-administration and targets the C5 component of the immune system.

The recommendation draws on the 260-patient PREVAIL Phase III study. At 26 weeks, the treatment improved the Myasthenia Gravis Activities of Daily Living score by 1.6 points more than placebo, with a statistically significant difference. AstraZeneca said the safety profile was consistent with previous C5-inhibitor studies. The positive CHMP opinion is an important regulatory step, but it is not the European Commission’s final marketing authorization.

Sources:

• AstraZeneca — Klygefa CHMP recommendation, RNS